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Pain in Trans Femoral and Trans Tibial Amputees (AMPUPHANTOM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03789435
Recruitment Status : Recruiting
First Posted : December 28, 2018
Last Update Posted : August 21, 2019
I.R.C.C.S. Fondazione Santa Lucia
Information provided by (Responsible Party):
Mariagrazia Benedetti, Istituto Ortopedico Rizzoli

Brief Summary:

Phantom limb is difficult to manage and has a significant impact on the patient's quality of life. At present, the scientific evidence shows that the infusion of local anesthetics with epidural and perineural catheters in the perioperative phase correlates with good pain control in the immediate post-operative, expressed in terms of reduced demand for opiates by the patient undergoing amputation. of lower limb. Few are studies that highlight the effectiveness of such treatments in the medium and long-term prevention of phantom limb syndrome.

The study aims to evaluate the incidence in the medium term of the phantom limb in trans femoral and trans tibial amputees and the possible relationship with the use of adequate pre and perioperative analgesia using peridural and peripheral nerve catheters. The results of the study could provide indications about the need to modify both the perioperative analgesic therapy protocol and also rehabilitation for lower limb amputation surgery in order to reduce the prevalence of phantom limb syndrome with consequent improvement in quality of life.

Condition or disease Intervention/treatment
Lower Limb Amputation Above Knee Lower Limb Amputation Below Knee Diagnostic Test: Questionnaire

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 170 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 7 Days
Official Title: Medium-term Incidence Study of Phantom Limb Syndrome in Trans Femoral and Trans Tibial Amputated Patients
Actual Study Start Date : March 7, 2019
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Limb Loss

Group/Cohort Intervention/treatment
Patients underwent trans-tibial and trans-femoral amputation of any etiology at the Rizzoli Orthopedic Institute from 2015 to 2017 with the presence of analgesia data for surgery in a computerized record (SIR, Rizzoli information system). A questionnaire for the detection of residual limb pain will be administrate to all the survivors.
Diagnostic Test: Questionnaire

A questionnaire from which the session dedicated to the evaluation of the stump pain, the phantom limb and the sensation of the phantom limb has been extracted will be administered: this is the Prosthetic Evaluation Questionnaire (PEQ) validated in Italian by Ferrero et al. 2005.

In the questionnaire sent to patients will be asked also for anthropometric data (weight, height) in addition to the characteristics of the worn prosthesis and if they have followed a period of rehabilitation.The time of use of the prosthesis will be evaluated through the Houghton Scale of Prosthetic Use in People with Lower- Extremity Amputations (19)

Primary Outcome Measures :
  1. Mid-term incidence (1 to 3 years) of pain in the stump or phantom limb and phantom limb sensation in amputated trans femoral and trans tibial patients treated at IOR from 2015 to 2017. [ Time Frame: 7 days ]
    Data will be obtained by means of questionnaire sent to patients.

  2. Evaluation of the type of anesthesia and perioperative analgesic treatment with peripheral nerve block effected and of the use of the prosthesis to evaluate possible relations with the presence and the entity of the phantom limb. [ Time Frame: 7 days ]
    Anesthesia data will be retrieved from patient records.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients amputated above and below the knee at the Orthopedic Divisions of the Rizzoli Orthopedic Institute

Inclusion criteria:

  • Patients undergoing trans-tibial and trans-femoral amputation of any etiology at the Rizzoli Orthopedic Institute from 2015 to 2017
  • Presence of analgesia data for surgery in a computerized record (SIR, Rizzoli information system)
  • Patients who have accepted to join the study

Exclusion criteria:

  • Patients with a medical record inaccessible via SIR (not yet digitized)
  • Deceased patients
  • Patients under the age of 18
  • Non-ambulatory patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03789435

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Contact: Maria Grazia Benedetti, MD 6366236 ext +39051

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IRCCS-Istituto Ortopedico Rizzoli Recruiting
Bologna, Italy, 40136
Contact: Maria Grazia Benedetti, MD    6366236 ext +39051   
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
I.R.C.C.S. Fondazione Santa Lucia
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Principal Investigator: Maria Grazia Benedetti IRCCS-Istituto Ortopedico Rizzoli

Additional Information:

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Responsible Party: Mariagrazia Benedetti, Head Physical Medicine and Rehabilitation Unit, Istituto Ortopedico Rizzoli Identifier: NCT03789435     History of Changes
Other Study ID Numbers: 0013569
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No